FDA 510(k)

Trinity ELE Plus 及 Trinity ELE Plus Pro

K号: K201906 · 2021-02-24

决定日期2021-02-24

产品代码NFO

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决定实质等同

器械摘要

Trinity ELE Plus and Trinity ELE Plus Pro is the device name listed in this FDA 510(k) record. The listed applicant is Carol Cole Company Dba Nuface. It received FDA 510(k) clearance on 2021-02-24 under 510(k) number K201906. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Trinity ELE Plus and Trinity ELE Plus Pro?

Trinity ELE Plus and Trinity ELE Plus Pro is a medical device that received FDA 510(k) clearance on 2021-02-24. The listed applicant is Carol Cole Company Dba Nuface. The 510(k) number is K201906.

When did Trinity ELE Plus and Trinity ELE Plus Pro receive FDA 510(k) clearance?

Trinity ELE Plus and Trinity ELE Plus Pro received FDA 510(k) clearance on 2021-02-24, under 510(k) number K201906.

Who is the listed applicant for Trinity ELE Plus and Trinity ELE Plus Pro?

The FDA 510(k) record lists Carol Cole Company Dba Nuface as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trinity ELE Plus and Trinity ELE Plus Pro?

The FDA product code for Trinity ELE Plus and Trinity ELE Plus Pro is NFO.

列明Carol Cole Company Dba Nuface为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K240564NuFACE® FIX+K212947Trinity Plus 纹纹减少器 K201782NuFace Trinity Plus 设备 K191672NuFACE Mini 设备 K182424NuFACE FIX 皮肤紧致设备 K181008NuFACE Trinity

查看所有 8 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。